When Training is a Root Cause: Handling Investigations of Suspected Performance Issues

Why Should You Attend:

FDA 483 and warning letter observations continue to cite inadequate investigations as a significant problem area for industry. How many of your investigations point to the individual who performed the task as not being competent? Because that’s really what it means when the root cause of “training” is assigned. Do you understand that these assignments also potentially implicate your entire training system as ineffective? Without digging a little deeper, you run the risk of receiving 2 significant observations. But what questions do you need to ask? How far down do you have to go? When is it a training issue and when is it a performance issue? And how do you support and encourage both the investigator and supervisor in being able to ask the right questions and determine appropriate corrective and preventive actions?

Investigations are not easy, not fun, and often disruptive to everyday work and the ability to meet important timelines. They are also a regulatory requirement as part of a robust quality system aimed at preventing risk to patients and others who use our products. When a task isn’t completed as required, often the individual is singled out as not being competent in that moment, and training is cited as both a root cause and as a corrective action. So why was this event different from all the other successful performances of that task, both before and after? And what do the conclusions say about the individual, our training program, and our willingness to truly understand and deal with what actually happened?

This webinar will give you practical strategies for continuing an investigation into a suspected performance/training/competency issue to arrive at a more meaningful root cause, and then give you the tools and support needed to address the underlying factors effectively and efficiently.

Areas Covered in the Webinar:

• Regulatory agency expectations for conducting investigations
• Why “training” often gets assigned as a root cause, and the inherent risks
• Distinguishing between competency, training and performance issues
• Asking the next layer of questions, and what to do with the answers
• Preventing regulatory scrutiny by assigning better root causes, and the language to use in justifying them
• Effective corrective and preventive actions for performance and competency-based root causes
• Using metrics to identify and prevent potential competency issues
• Overcoming challenges due to limited resources

Who Will Benefit:

• Quality Assurance professionals – associates/specialists, managers, directors
• Investigators – individuals who conduct lab or quality investigations
• Training professionals in regulated industries – trainers, associates/specialists, managers
• Clinical Development professionals – managers, supervisors, trainers
• Healthcare/medical professionals – managers, supervisors, trainers
• Production/Manufacturing managers, supervisors, leads, trainers
• Laboratory managers, supervisors and trainers
• Safety/EHS training managers, associates/specialists and trainers

From the following industries:

• Pharma, medical device, biologics, diagnostics, food, dietary supplements, healthcare/medical. Research, clinical and commercial scope

Free Materials:

• List of key questions to ask when Training is identified as a root cause

Mike Kent
Principal Consultant, Kent Quality Performance Group

As an independent consultant, Mike Kent helps solve performance challenges around both systems and people, enabling organizations to gain an edge along their research, development and commercial paths. He has over 28 years of quality and technical expertise in regulated environments across the pharmaceutical, medical device, biologics and diagnostic industries. Mike helps create and sustain a robust quality culture focused on good decision-making and engagement. A drug development chemist turned quality systems professional, he enjoys optimizing the interface between people and their work environments. Mike lives in Littleton, Colorado, with his son, and is a professional voice actor as the other half of his business, Kent Quality Performance Group. He spends his free time hiking, cycling, running and creating music and photographic art.

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